HyperparathyroidismIRIPHNCT02711059
Insulin Resistance in Primary Hyperparathyroidism
A study testing parathyroidectomy in people with Hyperparathyroidism and Diabetes, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
The aims of this study is to analyse if insulin resistance in primary hyperparathyroidism (pHPT) is normalised after parathyroid adenomectomy and if glucose tolerance test may be useful as a diagnostic tool by predicting potential improvement of insulin sensitivity after biochemical cure of pHPT. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hyperparathyroidism, Diabetes, Hypercalcemia
- What is being tested?
- parathyroidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2015to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary hyperparathyroidism and fb-glukos>6,1 and/or HbA1c > 39 mmol/mol
Who cannot join
- Treatment with insulin, sulfonylurea or metformin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Insulin Resistance in Primary Hyperparathyroidism, a Non-classical Manifestation
The aims of this study is to analyse if insulin resistance in primary hyperparathyroidism (pHPT) is normalised after parathyroid adenomectomy and if glucose tolerance test may be useful as a diagnostic tool by predicting potential improvement of insulin sensitivity after biochemical cure of pHPT.
Read the detailed description
To be conducted at the Karolinska University Hospital, Stockholm. Patients with fb-glucos >6.1 and HbA1c without medical treatment will be included after informed consent and randomised to parathyroidectomy (PTX) within three months or not. The groups will be examined 4 ±4 weeks before and 12±2 weeks after PTX, similar for the control group. The number of participants will be estimated by power calculations based on a pilot study including 20 patients.
The test protocol includes glucose load with control of glucose and insulin, (0, 30, 60 and 120 min) together with measurement of markers of oxidative stress and inflammation.
- Conditions
- Hyperparathyroidism, Diabetes, Hypercalcemia
- Being tested
- parathyroidectomy
- Keywords
- hyperparathyroidism, insulin resistance
- Medical subject headings
- Hyperparathyroidism, Diabetes Mellitus, Hypercalcemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parathyroidectomyProcedure or surgery
Also called parathyroid adenomectomy
surgical treatment of hyperparathyroidism
| Study group | Role | What they receive |
|---|---|---|
| parathyroidectomy | Active comparator | change in insulin resistance Receives: Procedure: parathyroidectomy |
| control | No intervention | the study participant will be examined parallel with the active comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
glucose tolerance test with estimation of insulin resistance
Homa IR
Measured: 3 months
quality of life - self estimation protocol
EORTC QLQ-C30
Measured: 3 months
Secondary outcomes (3)
psychological wellbeing
POMS
Measured: 3 months
anxiety, depression
HAD
Measured: 6 months
cognition
MoCA-Test
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startOct 2015
- Primary completionDec 2021 (estimated)
- Study completionJun 2022 (estimated)
Why it stopped: studien skjuts på framtiden
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperparathyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inga-Lena Nilsson, Karolinska University Hospital
- Investigators
- Inga-Lena Nilsson, MD, PhD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711059
- Sponsor's protocol ID
- KarolinskaUH_pHPT_diabetes
- Acronym
- IRIPH
- Status last verified
- Sep 2020
- First submitted
- 18 Oct 2015
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Norenstedt S, Pernow Y, Brismar K, Saaf M, Ekip A, Granath F, Zedenius J, Nilsson IL. Primary hyperparathyroidism and metabolic risk factors, impact of parathyroidectomy and vitamin D supplementation, and results of a randomized double-blind study. Eur J Endocrinol. 2013 Oct 21;169(6):795-804. doi: 10.1530/EJE-13-0547. Print 2013 Dec.
PubMed 24026893
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Resistance in Primary Hyperparathyroidism, a Non-classical Manifestation
- ClinicalTrials.gov ID
- NCT02711059
- Acronym / sponsor ID
- IRIPH / KarolinskaUH_pHPT_diabetes
- Conditions
- Hyperparathyroidism, Diabetes, Hypercalcemia
- Keywords
- hyperparathyroidism, insulin resistance
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: studien skjuts på framtiden
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 17 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aims of this study is to analyse if insulin resistance in primary hyperparathyroidism (pHPT) is normalised after parathyroid adenomectomy and if glucose tolerance test may be useful as a diagnostic tool by predicting potential improvement of insulin sensitivity after biochemical cure of pHPT.
Detailed description
To be conducted at the Karolinska University Hospital, Stockholm. Patients with fb-glucos >6.1 and HbA1c without medical treatment will be included after informed consent and randomised to parathyroidectomy (PTX) within three months or not. The groups will be examined 4 ±4 weeks before and 12±2 weeks after PTX, similar for the control group. The number of participants will be estimated by power calculations based on a pilot study including 20 patients.
The test protocol includes glucose load with control of glucose and insulin, (0, 30, 60 and 120 min) together with measurement of markers of oxidative stress and inflammation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| parathyroidectomy | Active comparator | Procedure: parathyroidectomychange in insulin resistance |
| control | No intervention | –the study participant will be examined parallel with the active comparator |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- primary hyperparathyroidism and fb-glukos>6,1 and/or HbA1c > 39 mmol/mol
Key exclusion criteria (1 listed)
- Treatment with insulin, sulfonylurea or metformin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| parathyroidectomyAlso: parathyroid adenomectomysurgical treatment of hyperparathyroidism | Procedure or surgery | parathyroidectomy |
Primary outcome
glucose tolerance test with estimation of insulin resistance
Time frame: 3 months
Homa IR
quality of life - self estimation protocol
Time frame: 3 months
EORTC QLQ-C30
3 secondary outcomes
psychological wellbeing
Time frame: 3 months
anxiety, depression
Time frame: 6 months
cognition
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Background: PubMed 24026893Norenstedt S, Pernow Y, Brismar K, Saaf M, Ekip A, Granath F, Zedenius J, Nilsson IL. Primary hyperparathyroidism and metabolic risk factors, impact of parathyroidectomy and vitamin D supplementation, and results of a randomized double-blind study. Eur J Endocrinol. 2013 Oct 21;169(6):795-804. doi: 10.1530/EJE-13-0547. Print 2013 Dec.
- Regional programLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Hyperparathyroidism
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A Study of PLS240 in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
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RecruitingPhase 4
Bisphosphonate Prior to Parathyroidectomy in Primary Hyperparathyroidism
Primary Hyperparathyroidism
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Natural History Study of Parathyroid Disorders
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Evaluation of the Role of Luteinizing Hormone (LH) and Human Chorionic Gonadotropin (hCG) in Adult Patients Undergoing Assessment for Endocrine Disorders
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inga-Lena Nilsson, MD, PhD principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing parathyroidectomy in people with Hyperparathyroidism and Diabetes, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glucose tolerance test with estimation of insulin resistance (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02711059, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020; AzTrials last refreshed its copy on 29 Oct 2026.